Overview
Insulin aspart is a rapid-acting form of insulin used for the treatment of hyperglycemia caused by Type 1 and Type 2 Diabetes. Insulin is typically prescribed for the management of diabetes mellitus to mimic the activity of endogenously produced human insulin, a peptide hormone produced by beta cells of the pancreas that promotes glucose metabolism. Insulin is released from the pancreas following a meal to promote the uptake of glucose from the blood into internal organs and tissues such as the liver, fat cells, and skeletal muscle. Absorption of glucose into cells allows for its transformation into glycogen or fat for storage. Insulin also inhibits hepatic glucose production, enhances protein synthesis, and inhibits lipolysis and proteolysis among many other functions. Insulin is an important treatment in the management of Type 1 Diabetes (T1D) which is caused by an autoimmune reaction that destroys the beta cells of the pancreas, resulting in the body not being able to produce or synthesize the insulin needed to manage circulating blood sugar levels. As a result, people with T1D rely primarily on exogenous forms of insulin, such as insulin aspart, to lower glucose levels in the blood. Insulin is also used in the treatment of Type 2 Diabetes (T2D), another form of diabetes mellitus that is a slowly progressing metabolic disorder caused by a combination of genetic and lifestyle factors that promote chronically elevated blood sugar levels. Without treatment or improvement in non-pharmacological measures such as diet and exercise to lower blood glucose, high blood sugar eventually causes cellular resistance to endogenous insulin, and in the long term, damage to pancreatic islet cells. Insulin is typically prescribed later in the course of T2D, after trying several oral medications such as Metformin, Gliclazide, or Sitagliptin have been tried, when sufficient damage has been caused to pancreatic cells that the body is no longer able to produce insulin on its own. Marketed as the brand name product NovoRapid, insulin aspart begins to exert its effects within 15 minutes of subcutaneous administration, while peak levels occur 30 to 90 minutes after administration. Due to its duration of action of around 5 hours, NovoRapid is considered "bolus insulin" as it provides high levels of insulin in a short period of time to mimic the release of endogenous insulin from the pancreas after meals. Bolus insulin is often combined with once daily, long-acting "basal insulin" such as Insulin detemir, Insulin degludec, and Insulin glargine to provide low concentrations of background insulin that can keep blood sugar stable between meals or overnight. Use of basal and bolus insulin together is intended to mimic the pancreas' production of endogenous insulin, with a goal of avoiding any periods of hypoglycemia. Insulin aspart is a recombinant, biosynthetic, fast-acting insulin analogue. Compared to human insulin, it has a single amino acid substitution at position B28 where proline is replaced with aspartic acid. This substitution decreases its propensity to form hexamers and gives it a higher rate of absorption following subcutaneous administration compared to native insulin. Insulin aspart is produced in a genetically modified strain of Saccharomyces cerevisiae (baker's yeast) Without an adequate supply of insulin to promote absorption of glucose from the bloodstream, blood sugar levels can climb to dangerously high levels and can result in symptoms such as fatigue, headache, blurred vision, and increased thirst. If left untreated, the body starts to break down fat, instead of glucose, for energy which results in a build-up of ketone acids in the blood and a syndrome called ketoacidosis, which is a life-threatening medical emergency. In the long term, elevated blood sugar levels increase the risk of heart attack, stroke, and diabetic neuropathy.
Indication
Insulin aspart is indicated to improve glycemic control in adults and children with diabetes mellitus.
Associated Conditions
- Diabetes Mellitus
- Diabetic Ketoacidosis
- Gestational Diabetes Mellitus (GDM)
- Hyperglycemia during critical illness
Research Report
An In-Depth Monograph on Insulin Aspart (DB01306): From Molecular Engineering to Clinical Practice
Executive Summary
Insulin aspart (DrugBank ID: DB01306) represents a cornerstone therapy in the management of diabetes mellitus. As a rapid-acting, recombinant human insulin analog, its development marked a significant milestone in biotechnology and rational drug design. The therapeutic innovation of insulin aspart is rooted in a single, targeted amino acid substitution—the replacement of proline with aspartic acid at position B28 of the insulin B-chain. This seemingly minor modification profoundly alters the molecule's physicochemical properties, reducing its propensity to form hexamers and enabling significantly faster absorption from subcutaneous tissue compared to regular human insulin. This accelerated pharmacokinetic profile translates directly into a more physiological pharmacodynamic response, allowing for effective control of postprandial glucose excursions when administered immediately before meals.
Clinically, insulin aspart is indicated for improving glycemic control in both Type 1 and Type 2 diabetes mellitus in adults and children. It is administered via subcutaneous injection, continuous subcutaneous infusion via an insulin pump, or intravenously in supervised clinical settings. Its efficacy is well-established, though its primary advantage, particularly in Type 2 diabetes, often lies in the enhanced convenience and quality of life it offers patients over older insulins. The safety profile is well-characterized and dominated by the risk of hypoglycemia, a direct extension of its glucose-lowering pharmacology.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/07/22 | Not Applicable | Not yet recruiting | |||
2025/07/16 | Not Applicable | Not yet recruiting | |||
2025/02/05 | Phase 1 | Recruiting | |||
2024/08/19 | Phase 2 | Recruiting | Gan and Lee Pharmaceuticals, USA | ||
2024/08/09 | Early Phase 1 | Recruiting | Anna Stanhewicz, PhD | ||
2024/08/01 | Not Applicable | Recruiting | |||
2024/01/10 | Phase 2 | Completed | Gan and Lee Pharmaceuticals, USA | ||
2023/11/13 | Phase 4 | Recruiting | Sun Yat-sen University | ||
2023/07/14 | Early Phase 1 | Recruiting | Anna Stanhewicz, PhD | ||
2023/07/14 | Early Phase 1 | Recruiting | Anna Stanhewicz, PhD |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Novo Nordisk | 0169-3205 | SUBCUTANEOUS | 100 [iU] in 1 mL | 6/21/2023 | |
Sanofi-Aventis U.S. LLC | 0024-5927 | SUBCUTANEOUS, INTRAVENOUS | 100 [iU] in 1 mL | 5/30/2025 | |
A-S Medication Solutions | 50090-4085 | SUBCUTANEOUS | 100 [iU] in 1 mL | 4/28/2021 | |
Novo Nordisk Pharma, Inc. | 73070-102 | INTRAVENOUS, SUBCUTANEOUS | 100 [iU] in 1 mL | 11/15/2019 | |
Novo Nordisk | 0169-3696 | SUBCUTANEOUS | 100 [iU] in 1 mL | 4/28/2021 | |
Novo Nordisk Pharma, Inc. | 73070-203 | SUBCUTANEOUS | 100 [iU] in 1 mL | 10/30/2020 | |
Physicians Total Care, Inc. | 54868-5201 | SUBCUTANEOUS | 100 [iU] in 1 mL | 6/15/2011 | |
Novo Nordisk | 0169-2101 | INTRAVENOUS, SUBCUTANEOUS | 100 [iU] in 1 mL | 2/28/2023 | |
Novo Nordisk | 0169-2200 | SUBCUTANEOUS | 100 [iU] in 1 mL | 4/28/2021 | |
REMEDYREPACK INC. | 70518-3236 | SUBCUTANEOUS | 100 [iU] in 1 mL | 3/14/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 1/21/2013 | ||
Authorised | 2/5/2021 | ||
Authorised | 8/1/2000 | ||
Authorised | 6/25/2020 | ||
Authorised | 4/25/2022 | ||
Authorised | 1/9/2017 | ||
Authorised | 9/7/1999 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
NOVORAPID PENFILL INJECTION 100 u/ml | SIN11394P | INJECTION | 100 u/ml | 9/12/2000 | |
FIASP SOLUTION FOR INJECTION IN VIAL 100U/ML | SIN15995P | INJECTION, SOLUTION | 600nmol/ml | 8/17/2020 | |
NOVORAPID FLEXPEN INJECTION 100 u/ml | SIN12189P | INJECTION | 100 u/ml | 2/6/2003 | |
FIASP FLEXTOUCH 100U/ML | SIN15994P | INJECTION, SOLUTION | 600nmol/ml | 8/17/2020 | |
NOVOMIX® 30 PENFILL® 100 U/ML | SIN15480P | INJECTION, SUSPENSION | 100 U/ ml | 5/9/2018 | |
RYZODEG® FLEXTOUCH® SOLUTION FOR INJECTION IN PRE-FILLED PEN 100 U/ml | SIN15706P | INJECTION, SOLUTION | 180nmol/ml | 5/31/2019 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
RYZODEG FLEXTOUCH SOLUTION FOR INJECTION IN PRE-FILLED PEN 100U/ML 70/30 3ML | N/A | novo nordisk hong kong ltd. | N/A | N/A | 4/28/2025 |
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
KIRSTY | biocon sdn.bhd | 02520974 | Solution - Subcutaneous | 100 UNIT / ML | 10/20/2022 |
TRURAPI | sanofi-aventis canada inc | 02506564 | Solution - Subcutaneous | 100 UNIT / ML | 3/30/2021 |
NOVORAPID | Novo Nordisk Canada Inc | 02377209 | Solution - Subcutaneous | 100 UNIT / ML | 5/4/2012 |
NOVORAPID | Novo Nordisk Canada Inc | 02245397 | Solution - Subcutaneous | 100 UNIT / ML | 6/12/2002 |
FIASP | Novo Nordisk Canada Inc | 02460408 | Solution - Subcutaneous | 100 UNIT / ML | 3/3/2017 |
NOVOMIX 30 | Novo Nordisk Canada Inc | 02265435 | Suspension - Subcutaneous | 70 UNIT / ML | 9/12/2005 |
NOVOMIX 30 | Novo Nordisk Canada Inc | 02265435 | Suspension - Subcutaneous | 30 UNIT / ML | 9/12/2005 |
FIASP | Novo Nordisk Canada Inc | 02460416 | Solution - Subcutaneous | 100 UNIT / ML | 3/3/2017 |
NOVOMIX 30 (FLEXPEN) | Novo Nordisk Canada Inc | 02265443 | Suspension - Subcutaneous | 30 % | N/A |
NOVOMIX 30 (FLEXPEN) | Novo Nordisk Canada Inc | 02265443 | Suspension - Subcutaneous | 70 % | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
FIASP 100 UNIDADES/ML FLEXTOUCH SOLUCION INYECTABLE EN PLUMA PRECARGADA | 1161160001 | SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized | |
RYZODEG 100 UNIDADES/ML SOLUCION INYECTABLE EN PLUMA PRECARGADA | 12806001 | SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
NOVOMIX 30 FLEXPEN 100 U/ML SUSPENSION INYECTABLE EN UNA PLUMA PRECARGADA | 00142009 | SUSPENSIÓN INYECTABLE EN JERINGA PRECARGADA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized | |
NOVOMIX 50 FLEXPEN 100 U/ML SUSP. INYECTABLE EN UNA PLUMA PRECARGADA | 00142015 | SUSPENSIÓN INYECTABLE EN JERINGA PRECARGADA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized | |
FIASP 100 UNIDADES/ML PUMPCART SOLUCION INYECTABLE EN CARTUCHO | 1161160012 | SOLUCIÓN INYECTABLE EN CARTUCHO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized | |
NOVOMIX 70 FLEXPEN 100 U/ML SUSP. INYECTABLE EN UNA PLUMA PRECARGADA | 00142021 | SUSPENSIÓN INYECTABLE EN JERINGA PRECARGADA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized | |
NOVORAPID 100 U/ML SOLUCION INYECTABLE EN VIAL | 99119001 | SOLUCIÓN INYECTABLE | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized | |
NOVORAPID PENFILL 100 U/ML SOLUCION INYECTABLE EN CARTUCHO | 199119003 | SOLUCIÓN INYECTABLE | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized | |
FIASP 100 UNIDADES/ML SOLUCION INYECTABLE EN VIAL | 1161160007 | SOLUCIÓN INYECTABLE | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized | |
NOVORAPID FLEXPEN 100 U/ML SOLUCION INYECTABLE EN UNA PLUMA PRECARGADA | 99119009 | SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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